| CTRI Number |
CTRI/2026/01/101095 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to evaluate the Safety and Immunogenicity of Typhoid Bivalent Conjugate Vaccine in Healthy Male Subjects |
|
Scientific Title of Study
|
An Open label Phase I Study to evaluate the Safety and Immunogenicity of Typhoid Bivalent Conjugate Vaccine of HBI when administered to Healthy Male Subjects of 18 to 50 years of age. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HBI/Typ1/25/01.1.1 Version 01 Amendment 01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sai Krishna |
| Designation |
GM Medical Veterinary services |
| Affiliation |
Human Biologicals Institute |
| Address |
Medical and veterinary Department
Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad – 500 032, Telangana
Medical and veterinary Department
Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad – 500 032, Telangana
Hyderabad
TELANGANA
500032
India |
| Phone |
9948436440 |
| Fax |
|
| Email |
s.saikrishna@indimmune.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sai Krishna |
| Designation |
GM Medical Veterinary services |
| Affiliation |
Human Biologicals Institute |
| Address |
Medical and veterinary Department
Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad – 500 032, Telangana
Medical and veterinary Department
Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad – 500 032, Telangana
Hyderabad
TELANGANA
500032
India |
| Phone |
9948436440 |
| Fax |
|
| Email |
s.saikrishna@indimmune.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sai Krishna |
| Designation |
GM Medical Veterinary services |
| Affiliation |
Human Biologicals Institute |
| Address |
Medical and veterinary Department
Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad – 500 032, Telangana
Medical and veterinary Department
Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad – 500 032, Telangana
Hyderabad
TELANGANA
500032
India |
| Phone |
9948436440 |
| Fax |
|
| Email |
s.saikrishna@indimmune.com |
|
|
Source of Monetary or Material Support
|
| Human Biologicals Institute Rakshapuram Gachibowli Hyderabad 500032 |
|
|
Primary Sponsor
|
| Name |
Human Biologicals Institute |
| Address |
Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad – 500 032, Telangana |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahendra Singh |
All India Institute of Medical Sciences |
Department of Community and Family Medicine
All India Institute of Medical Sciences
Virbhadra Road Rishikesh Uttarakhand 249 203 India
Dehradun
UTTARANCHAL |
9799624704
gehlot.mahendrasingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee relating to Clinical Trial All India Institute Of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of Typhoid and Paratyphoid infections |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Typhoid bi-valent conjugate vaccine |
Subjects will receive single dose of 0.5 mL Typhoid bi-valent conjugate vaccine by intramuscular route in deltoid region in the upper arm. The subjects will be followed up till 180 days after the single dose of vaccination. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1.Healthy male subjects of 18 to 50 years of age.
2.Judged to be in good health on the basis of reported medical history, physical examination, laboratory investigations and clinical judgement of the investigator.
3.Plans to remain in the study area for the entire length of the trial.
4.Subject is literate and has understood and provided written Informed Consent.
|
|
| ExclusionCriteria |
| Details |
1.Participation in any other clinical trial in the four weeks preceding the trial vaccination.
2.Subjects who have previously received any vaccines against typhoid fever.
3.Subjects who have a previously ascertained or suspected disease caused by S. Typhi or S. Paratyphi A.
4.Any household member having or exposed to an individual with laboratory confirmed S. Typhi or S. Paratyphi A.
5.Planned participation in any other clinical trial during the present trial period.
6.Subject who has a known history of allergy to any component of the vaccine.
7.Known or suspected primary or acquired disease of the immune system.
8.Receiving allergy immunotherapy or immunosuppressive therapy or systemic/oral corticosteroids.
9.History of any significant underlying disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, diabetes, hypertension, hematologic or hepatic dysfunction and autoimmune disease.
10.Known or suspected acute respiratory illness at the time of study vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis and respiratory problems (e.g. asthma, wheezing, shortness of breath).
11.Any fever with temperature Greater than or equal to 38.0°C (100.4oF) in last 3 days prior to the study vaccination
12.Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures or evidence of any other evolving neurological signs and symptoms.
13.Any known history or suspicion of thrombocytopenia or a bleeding disorder.
14.History of alcoholism or drug abuse.
15.Any history of receipt of blood products or immunoglobulins in last 3 months.
16.Subjects who have received any live attenuated vaccine in past 30 days and any subunit or inactivated vaccine except for tetanus toxoid vaccine in past 14 days.
17.Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety
1.Solicited/unsolicited local adverse events after a single dose vaccination and during the 28 days follow-up period.
2.Solicited/unsolicited systemic adverse events after a single dose vaccination and during the 28 days follow-up period.
3.Occurrence of serious adverse events during the study period. |
Solicited/unsolicited local and systemic adverse events up to the 28 days follow-up period.
Serious adverse events for entre study period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Seroconversion rates for anti-Vi IgG and anti-Vi IgA antibody titres against S. Typhi on Days 28, 90 and 180 after vaccination.
2.Seroconversion rates for anti-OPS and SBA antibody titres against S. Paratyphi A on Days 28, 90 and 180 after vaccination.
3. GMTs of anti-Vi IgG and anti-Vi IgA antibodies against S. Typhi at pre-vaccination, and on Days 28, 90 and 180 post vaccination.
4.GMTs of SBA for paratyphoid A antigen against S. Paratyphi A at pre-vaccination and on Days 28, 90 and 180 post vaccination.
5.GMTs of anti-O-polysaccharide IgG antibodies measured by ELISA against S. Paratyphi A at pre-vaccination and on Days 28, 90 and 180 post vaccination.
Exploratory
1. Seroconversion rates for anti-Vi IgG and anti-Vi IgA antibody titres against S. Typhi on Day 28 after vaccination in subjects with pre-existing seroprotective anti-tetanus antibody titres.
2.Seroconversion rates for anti-OPS and SBA antibody titres against S. |
1. Seroconversion rates for anti-Vi IgG and anti-Vi IgA anti body titers against S. Typhi on Days 28, 90 and 180 after vaccination.
2. Seroconversion rates for anti-OPS and SBA antibody titres against S. Paratyphi A on Days 28, 90 and 180 after vaccination.
3.GMT of anti-Vi IgG and anti-Vi IgA anti bodies against S. Typhi at pre-vaccination and on Days 28, 90 and 180 after vaccination.
4. GMT of anti-OPS and SBA antibodies against S. Paratyphi A at pre-vaccination and on Days 28, 90 and 180 after vaccination. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
30/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This This is An Open label Phase I clinical trial to evaluate the Safety and Immunogenicity
of Typhoid Bivalent Conjugate Vaccine of HBI administered in Healthy Male Subjects.
66 subjects will be enrolled in a single centre. The primary objectives are to
evaluate the safety of Typhoid Bivalent Conjugate Vaccine of HBI in healthy
male subjects of 18 to 50 years of age, proportion of the subjects experiencing
local and/or systemic adverse events during follow up period and the occurrence
of serious adverse events during follow up period. The Secondary objective is
to determine the humoral immune response after administration of Typhoid
Bivalent Conjugate Vaccine of HBI in healthy male subjects and the exploratory
objectives are to determine the effect of pre-existing anti-tetanus antibodies
on the immune responses to typhoid and paratyphoid A. Subjects meeting the
inclusion/exclusion criteria will receive single dose (0.5 ml) of the vaccine
by intramuscular injection. Subjects will be followed up for 180 days after the
vaccination. Blood samples for the antibody titres estimation will be collected
from all the enrolled subjects before vaccination on Day 0 (Visit 2), Day 28
(Visit 3), Day 90 (Visit 4) and Day 180 (Visit 5) for measuring anti-Vi IgG and
IgA antibodies against S. Typhi and anti-O-polysaccharide IgG antibodies
against S. Paratyphi A and functional antibodies using serum bactericidal assay
(SBA) against S. Paratyphi A. Also, Anti-tetanus antibodies will be measured on
Visit 2(Day 0) and Day 28 (Visit 3). |